The invention relates to systems and methods for applying low energy emission therapy for the treatment of central nervous system disorders.
Low energy emission therapy involving application of low energy electromagnetic emissions to a patient has been found to be an effective mode of treating a patient suffering from central nervous system (CNS) disorders such as generalized anxiety disorders, panic disorders, sleep disorders including insomnia, circadian rhythm disorders such as delayed sleep, psychiatric disorders such as depression, obsessive compulsive disorders, disorders resulting from substance abuse, sociopathy, post traumatic stress disorders or other disorders of the central nervous system. Apparatus and methods for carrying out such treatment are described in U.S. Pat. Nos. 4,649,935 and 4,765,322, assigned to the same assignee as the present application, the disclosures of which are expressly incorporated herein by reference. Since the time of these earlier disclosures, a substantially greater understanding of the mechanisms of the treatment and how to secure best results has been gained, which has led to important developments being made to the apparatus (herein described as a system).
Although the apparatus and methods described in the above patents have provided satisfactory results in many cases, consistency and significance of results has sometimes been lacking. Also, it was not always possible to properly control or monitor the duration of treatment or the quantities or nature of the low energy emissions being applied to the patient. Furthermore, the efficiency of transfer of the low energy emissions to the patient was limited and was affected by such factors as patient movement, outside interference and the like.
Another limitation of the previously described apparatus is that it is not very amenable to ready marketing by marketing organizations specifically of the nature comprised in the pharmaceutical industry. The apparatus is intended for therapy or treatment of patients and the low energy emissions applied to the patient are akin to pharmaceutical medication. The marketing organization of a pharmaceutical industry should thus be placed in a position to market the therapy in a fashion not widely different from the fashion in which pharmaceutical products are marketed, e.g., through pharmacists, with or without a doctor's prescription.
Research on treatment for insomnia has lagged behind other medical research programs. Current treatment methods for insomnia consist either of hypnotics, behavioral therapies (e.g. biofeedback), or of the use of drug agents, specifically benzodiazepines or imidazopyridines. Tolerance, dependence, memory loss, and lack of efficacy in long-term treatment are among the most common drawbacks of these classes of currently available hypnotics.
Research throughout the past two decades has shown clearly that the brain serves not only as a communication link and thought-processing organ, but also as the source of significant chemical activity, as well as a number of bioactive compounds. Many of these neurotransmitter compounds and ions are secreted following chemical or electrical stimuli. Research has also shown that some of these neuroactive compounds are involved in the regulation of sleep and wake cycles (Koella, "The Organization and Regulation of Sleep," Experientia, 1984; 40(4): 309-408).
During the 1970s, Adey and his group demonstrated that weak electromagnetic fields, modulated at certain well-defined low frequencies, were able to modify the release of ions (calcium) and neurotransmitters (GABA) in the brain (Kaczmarek and Adey, "The Eflux of .sup.45 Ca.sup.2+ and [.sup.3 H]y-aminobutyric Acid from Cat Cerebral Cortex," Brain Research, 1973; 63:331-342; Kaczmarek and Adey, "Weak Electronic Gradients Change Ionic and Transmitter Fluxes in Cortex," Brain Research, 1974; 66:537-540; Bawin et al., "Ionic Factors in Release of .sup.45 Ca.sup.2+ From Chicken Cerebral Tissue by Electromagnetic Fields," Proceedings of the National Academy of Science, 1978; 75(12):6314-6318). In these experiments the cortex of anaesthetized cats was initially incubated with radio-labeled calcium and radio-labeled GABA. When the cortex was exposed to continuous stimulation by weak electric fields modulated at 200 Hz, the researchers found a 1.29-fold increase in Ca++ and a 1.21-fold increase in GABA release (Kaczmarek and Adey, Brain Research, 1973; 63:331-342). Interestingly, the release of GABA happened in parallel with the release of Ca++, suggesting that the two phenomena are closely linked. The findings of increased Ca++ release from brain tissue upon stimulation with modulated electromagnetic fields have been replicated (Dutta et al., "Microwave Radiation Induced Calcium Ions Effused from Human Neuroblastoma Cells in Culture," Bioelectromagnetics, 1984; 5(1):71-78; and Blackman et al., "Influence of Electromagnetic Fields on the Efflux of Calcium Ions from Brain Tissue in Vitro," Bioelectromagnetics, 1988; 9:215-227). It now has become an established fact that weak electric fields modulated at certain low frequencies are able to modulate the release of Ca++ and GABA.
During 1983, it was discovered that weak electromagnetic fields, modulated at low frequencies and delivered by means of an antenna placed in the buccal cavity, caused changes in EEG readings in human volunteers. In agreement with the findings of Adey and Blackman, it was found that only certain well-defined low frequency modulations of a standard carrier frequency (27 MHz), emitted with a well-defined intensity, were capable of eliciting EEG changes.